FDA Label for Maximum Strength Betadine Clear
View Indications, Usage & Precautions
Maximum Strength Betadine Clear Product Label
The following document was submitted to the FDA by the labeler of this product Atlantis Consumer Healthcare, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active ingredients
Benzalkonium Cl 0.13%
Pramoxine HCl 1.0%
Purpose
First aid Antiseptic
Topical analgesic
Uses
First aid to help prevent infection and relieve pain or discomfort in minor
• cuts• scrapes• burns
Warnings
For external use only
Do Not Use
• in the eyes• over large areas of the body
Ask A Doctor Before Use If You Have
• deep or puncture wounds• serious burns• animal bites
Stop Use And Ask A Doctor If
• condition or symptoms get worse or last more than 1 week• Symptoms clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Directions
• adults and children 2 years of age and older:• clean the affected area• spray a small amount of this product on the area 1 to 3 times daily• may be covered with sterile bandage• if bandaged, let dry first• children under 2 years of age:• consult a doctor
Other Information
• protect from freezing
Inactive Ingredients
citric acid anhydrous, disodium edetate, flavor, propylene glycol, purified water, sodium citrate dihydrate.
Package Label.Principal Display Panel
Principal Display Panel
MAXIMUM STRENGTH
BETADINE® CLEAR
FIRST AID SPRAY
Pain Relieving
Antiseptic
Cleansing spray
✓ Ideal for Minor Cuts, wounds, scrapes & Burns✓ Kills 99.9% of Germs* To prevent Infection✓ Maximum Strength Pain Relief✓ No Stinging or Burning
6 FL OZ (177 mL)
Dist. by: Atlantis Consumer Healthcare Inc.
Bridgewater, NJ 08807 USA
©2023 Atlantis Consumer Healthcare Inc.
*commonly associated with skin infections.
Tamper-Evident: Do not use if imprinted shrink band is broken or missing.
Betadine is a registered trademark of Atlantis Consumer Healthcare Inc.
* Please review the disclaimer below.